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Oral Contraceptive (OC) Progestin Dose and Breast Proliferation

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ClinicalTrials.gov Identifier: NCT00972439
Recruitment Status : Completed
First Posted : September 7, 2009
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Southern California

Tracking Information
First Submitted Date  ICMJE September 3, 2009
First Posted Date  ICMJE September 7, 2009
Results First Submitted Date  ICMJE February 14, 2013
Results First Posted Date  ICMJE February 23, 2018
Last Update Posted Date February 23, 2018
Study Start Date  ICMJE August 2007
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2018)
Breast Cell Proliferation Levels Between the Two Oral Contraceptive Dose Groups [ Time Frame: 32 weeks ]
Percent of cells expressing staining for Ki67 will be examined in breast epithelial cells
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2009)
To measure breast cell proliferation levels between the two oral contraceptive dose groups.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Contraceptive (OC) Progestin Dose and Breast Proliferation
Official Title  ICMJE Evaluating the Effect of Oral Contraceptive Progestin Dose on Breast Epithelial Cell Proliferation
Brief Summary The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of progestin; this research will examine that in detail.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Oral Contraceptive
Intervention  ICMJE
  • Drug: Oral Contraceptive: Ortho-Novum® 1/35
  • Drug: Oral Contraceptive: Ovcon Fe®
Study Arms  ICMJE
  • Active Comparator: Ortho-Novum® 1/35
    Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin.
    Intervention: Drug: Oral Contraceptive: Ortho-Novum® 1/35
  • Active Comparator: Ovcon Fe®
    Ovcon Fe® is an oral contraceptive that contains less progestin.
    Intervention: Drug: Oral Contraceptive: Ovcon Fe®
Publications * Hovanessian-Larsen L, Taylor D, Hawes D, Spicer DV, Press MF, Wu AH, Pike MC, Pearce CL. Lowering oral contraceptive norethindrone dose increases estrogen and progesterone receptor levels with no reduction in proliferation of breast epithelium: a randomized trial. Contraception. 2012 Sep;86(3):238-43. doi: 10.1016/j.contraception.2011.12.015. Epub 2012 Feb 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2018)
33
Original Actual Enrollment  ICMJE
 (submitted: September 4, 2009)
40
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-34.
  2. Premenopausal.
  3. Currently taking or want to start oral contraceptives for contraception
  4. Non-smoker.
  5. Competent to give informed consent (as judged by the investigator).
  6. Provided written informed consent.
  7. Willingness to refrain from smoking and consumption of grapefruit or grapefruit juice during the study (grapefruit interferes with metabolism of exogenously administered OCs).

Exclusion Criteria:1.

  1. Abnormal breast examination.
  2. History or current therapeutic or prophylactic use of anticoagulants.
  3. Known bleeding disorder or history of unexplained bleeding or bruising.
  4. History of breast cancer or previous diagnostic breast biopsy.
  5. Known allergy to local anesthetic.
  6. Currently pregnant or pregnant within the previous 6 months.
  7. Having any standard contra-indication to being prescribed OCs.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 34 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00972439
Other Study ID Numbers  ICMJE HS-07-00269
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: DeShawn Taylor, M.D. University of Southern California
PRS Account University of Southern California
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP